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Study withdrawn from IRB approval process by PI
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The purpose of this research project is to compare three different methods for fixation of hammertoe deformities: (1) Kirschner wire; (2) Integra IPP-ON PIP Fusion System; and (3) Stryker Smart-Toe implant.
This is a prospective, randomized study and will assist us in ascertaining which of the three tested interventions has the most beneficial outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kirschner wire | Active Comparator | surgical fixation using a Kirschner wire |
|
| Integra IPP-On PIP Fusion System | Active Comparator | surgical fixation utilizing the Integra IPP-On PIP Fusion System |
|
| Stryker Smart-Toe implant | Active Comparator | surgical fixation utilizing the Stryker Smart-Toe implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kirschner wire | Procedure | Surgical fixation utiliziing Kirschner wire |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Will look at number of participants with complications/adverse events including: floating toe, recurrence of hammertoe, soft tissue infection, medial/lateral mal-alignment at PIP joint, plantar flexion/hyperextension mal-alignment at DIP joint, rotation of toe and need for revision surgery. | change from baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Outcome | Will look at functional outcomes of patients as reported in the Foot and Ankle Ability Measure (FAAM) questionnaire administered to patients to assess their function pre- and post-surgery. | change from baseline to 12 weeks |
| Patient Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Umur Aydogan, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10694020 | Background | Coughlin MJ, Dorris J, Polk E. Operative repair of the fixed hammertoe deformity. Foot Ankle Int. 2000 Feb;21(2):94-104. doi: 10.1177/107110070002100202. | |
| 3656240 | Background | Reece AT, Stone MH, Young AB. Toe fusion using Kirschner wire. A study of the postoperative infection rate and related problems. J R Coll Surg Edinb. 1987 Jun;32(3):158-9. No abstract available. |
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| ID | Term |
|---|---|
| D037801 | Hammer Toe Syndrome |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D001864 | Bone Wires |
| ID | Term |
|---|---|
| D016268 | Internal Fixators |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D009984 | Orthopedic Fixation Devices |
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| Integra IPP-On PIP Fusion System |
| Procedure |
surgical fixation utilizing the Integra IPP-On PIP Fusion System |
|
| Stryker Smart-Toe Implant | Procedure | surgical fixation utilizing the Stryker Smart-Toe Implant |
|
Will look at overall patient satisfaction with surgical care via a questionnaire administered to patients. |
| change from baseline to 12 weeks |
| 8520664 | Background | Zingas C, Katcherian DA, Wu KK. Kirschner wire breakage after surgery of the lesser toes. Foot Ankle Int. 1995 Aug;16(8):504-9. doi: 10.1177/107110079501600809. |
| 22381341 | Background | Klammer G, Baumann G, Moor BK, Farshad M, Espinosa N. Early complications and recurrence rates after Kirschner wire transfixion in lesser toe surgery: a prospective randomized study. Foot Ankle Int. 2012 Feb;33(2):105-12. doi: 10.3113/FAI.2012.0105. |
| 8563920 | Background | Lehman DE, Smith RW. Treatment of symptomatic hammertoe with a proximal interphalangeal joint arthrodesis. Foot Ankle Int. 1995 Sep;16(9):535-41. doi: 10.1177/107110079501600904. |
| 15132935 | Background | Caterini R, Farsetti P, Tarantino U, Potenza V, Ippolito E. Arthrodesis of the toe joints with an intramedullary cannulated screw for correction of hammertoe deformity. Foot Ankle Int. 2004 Apr;25(4):256-61. doi: 10.1177/107110070402500411. |
| 7550962 | Background | Sarrafian SK. Correction of fixed hammertoe deformity with resection of the head of the proximal phalanx and extensor tendon tenodesis. Foot Ankle Int. 1995 Jul;16(7):449-51. doi: 10.1177/107110079501600714. |
| 22224327 | Background | Konkel KF, Sover ER, Menger AG, Halberg JM. Hammer toe correction using an absorbable pin. Foot Ankle Int. 2011 Oct;32(10):973-8. doi: 10.3113/FAI.2011.0973. |
| Background | Gadkari K, et al. A Prospective Comparison of a Permanent Intramedullary Device to K-Wire Fixation for Proximal Interphalangeal Joint Fusion: Early Results. Presented at AAOS Annual Meeting 2013, AOFAS Specialty Day |
| 16309613 | Background | Martin RL, Irrgang JJ, Burdett RG, Conti SF, Van Swearingen JM. Evidence of validity for the Foot and Ankle Ability Measure (FAAM). Foot Ankle Int. 2005 Nov;26(11):968-83. doi: 10.1177/107110070502601113. |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D053831 | Surgical Fixation Devices |